Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy.

NCT ID: NCT01824251

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-09-30

Brief Summary

Patients diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy were confirmed based on the European Federation of Neurological Societies/ Peripheral. Nerve Society Guideline. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, patients receive NPB-01 1g/kg every 3weeks and evaluate the Inflammatory Neuropathy Cause and Treatment（INCAT） score and INCAT sensory sumscore（ISS） et al.

As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by one year after the start of the study treatment.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NPB-01

Intravenous immunoglobulin

Group Type: EXPERIMENTAL

NPB-01

Intervention Type: DRUG

Interventions

NPB-01

Intervention Type: DRUG

Other Intervention Names

Intravenous immunoglobulin

Eligibility Criteria

Inclusion Criteria

• 1. Patients with progressive or relapsing motor and sensory dysfunction of more than one limb resulting from neuropathy within 2 months prior to the date informed consent is obtained.
• 2. Patients who INCAT score between 2-9. (If the INCAT score is 1 in upper limb, the INCAT score of 2 must be exclusively from leg disability to qualify.)
• 3. Patients who need high-dose intravenous immunoglobulin therapy.
• 4. Patients who continued treatment for CIDP without addition or increase at 30 days before informed consent.
• 5. Patients with greater than or equal to twenty years old at informed consent.

Exclusion Criteria

• 1. Patients with evidence of myelopathy or demyelination of central nerve
• 2. Patients with evidence of stroke, central nerve system trauma, or persistent neurological deficits due to peripheral neuropathy from other causes（diabetic neuropathy, IgM paraproteinaemia, uraemic neuropathy, toxic neuropathy, hereditary neuropathy）
• 3. Patients with evidence of neuropathy or alcoholic neuropathy or vitamin deficiency neuropathy due to myeloma, lymphoma, sarcoidosis, systemic lupus erythematosus, malignancy, vasculitis, Crow-Fukase syndrome, Sjögren syndrome.
• 4. Patients with multifocal motor neuropathy.
• 5. Patients treated with plasmapheresis at 3 months before informed consent.
• 6. Patients treated with rituximab at 6 months before informed consent.
• 7. Patients treated with high-dose intravenous immunoglobulin（greater than or equal to 1g/kg） at 8 weeks before informed consent.
• 8. Patients treated with intravenous immunoglobulin at 3 weeks before informed consent.
• 9. Patients with history of shock or hypersensitivity for NPB-01.
• 10. Patients with IgA deficiency.
• 11. Patients with malignancy at informed consent.
• 12. Patients with impaired liver function.
• 13. Patients with impaired renal function.
• 14. Patients with cerebro- or cardiovascular disorders.
• 15. Patients with high risk of thromboembolism.
• 16. Patients with hemolytic/hemorrhagic anemia.
• 17. Patients with decreased cardiac function.
• 18. Patients with decreased platelet.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nihon Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nihon Pharmaceutical Co., Ltd

Osaka, , Japan

Countries

Japan

References

Kuwabara S, Mori M, Misawa S, Suzuki M, Nishiyama K, Mutoh T, Doi S, Kokubun N, Kamijo M, Yoshikawa H, Abe K, Nishida Y, Okada K, Sekiguchi K, Sakamoto K, Kusunoki S, Sobue G, Kaji R; Glovenin-I CIDP Study Group. Intravenous immunoglobulin for maintenance treatment of chronic inflammatory demyelinating polyneuropathy: a multicentre, open-label, 52-week phase III trial. J Neurol Neurosurg Psychiatry. 2017 Oct;88(10):832-838. doi: 10.1136/jnnp-2017-316427. Epub 2017 Aug 2.

Reference Type: DERIVED

PMID: 28768822 (View on PubMed)

Other Identifiers

NPB-01-09/C-01

Identifier Type: -

Identifier Source: org_study_id